Within large-scale commercial antibody manufacturing, professionals like Mark Davis face significant challenges, daily. As the Director of MSAT at AGC Biologics, Mark is responsible for the scientists and engineers who anticipate, identify, and solve the technical challenges of manufacturing. To do this job requires a solid working knowledge of statistics, fluid engineering, and protein structural properties.
As a leader, Mark spends much of his time coordinating with other departments to ensure they are moving towards the same goals on the same timelines. His daily work involves addressing issues as they are escalated, ensuring deadlines are met, and updating and revising procedures and policies so that the team has the best systems for meeting the expectations of our developer partners who entrust us with their drug products.
From the diverse characteristics of each product they are working on with a pharmaceutical partner, to the constant evolution of regulatory expectations, his team must maintain a balance between efficiency, reliability, and compliance. In a recent interview,
Mark shared insights into these challenges and highlighted one key thing that drives a successful CDMO/developer partner relationship - dedicated collaboration and transparency.
What are some ways to reach a mutually transparent relationship?
Mark advocates for increased sharing of experiences and solutions that can lead to collective growth. One of the things we focus on at AGC Biologics is creating open discussions, we also find it helpful to share the latest publications and research from across the industry, to ensure both AGC Biologics and our developer partners understand the latest trends, technologies, and processes and how we can together explore the best way to manufacture their product.
It is also important to find balance when multiple stakeholders are involved and find simple solutions, particularly when producing large-scale commercial batches like Mark and his team do in Boulder.
When there are interactions with government regulators, quality teams at the CDMO and the developer partner, things can become too complicated quickly with many stakeholders involved in the conversation. It is important to find the right balance and create, create simple and reliable workflows, and communicate using terminology everyone understands.
Despite the similarities in technologies and approaches across biotech companies, each organization tackles problems differently. So, Mark and his team focus on creating a culture and process built on open dialogue, honest conversations and transparency with partners, regulators and other internal and external stakeholders.
How CDMOs Can Help Encourage Collaboration
CDMOs play a crucial role in refining processes, streamlining activities, and adhering to schedules to meet release specifications for developers, and it is our responsibility to ensure the smooth transition of drug development to the commercial stage.
In his work, there are a few key areas Mark tries to guide his team to focus on, such as the importance of understanding validation processes, helping developers keep their timelines, and creating realistic project management goals and standards to avoid over-commitment and subsequent delivery challenges.
Leaders like Mark play a pivotal role in this experience, as the MSAT team at AGC Biologics is entrusted with transferring processes, writing records, and delivering essential documents to support drug development. The MSAT group emphasizes providing effective risk assessments, experiment protocols, and timely deliverables without compromising quality.
Continuous improvement is also a key focus. By striving to improve and meet the developer’s exact specifications, it allows the AGC Biologics MSAT group to enhance their support and help our partners advance their drug substances to clinical and commercial stages, as quickly and effectively as possible.
CDMOs can significantly impact the lives of customers and patients by providing transparent feedback, supported by data. Whether customers are at the final stages or just beginning their projects, sharing the capabilities and even limitations of the CDMO is crucial for establishing trust. An open and honest environment fosters better collaboration, enabling customers to make informed decisions that ultimately benefit patients.
The challenges in large-scale commercial antibody manufacturing are multifaceted, but Mark envisions a future where increased collaboration, transparency, and honest communication lead to advancements in the industry, ultimately benefiting patients worldwide.
